| Summary: | Jing Zhao,1,* Xiaoliang Liu,2,* Weiping Wang,2 Ke Hu,2 Fuquan Zhang,2 Xiaorong Hou,2 Qingyu Meng2 1Department of Oncology, Beijing Shijitan Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Department of Radiation Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China *These authors contributed equally to this work Purpose: The purpose of this study was to evaluate the efficacy and toxicity of concomitant dose-escalated Tomotherapy in locally advanced mid–low rectal cancer. Patients and methods: Patients with locally advanced (T3/T4 or N+), low–mid (≤10 cm from anal verge) rectal carcinoma treated with neoadjuvant chemoradiotherapy followed by surgery between May 2012 and October 2017 in Peking Union Medical College Hospital were included in this study. A dose of 45/50 Gy in 25 fractions was delivered to the pelvis with Tomotherapy, and 55 Gy was prescribed for the primary tumor with a simultaneous, integrated boost. Megavolt computed tomography was performed before every delivery. The concurrent chemotherapy regimen included capecitabine alone and XELOX. Results: A total of 141 patients were enrolled; 129 patients (91.5%) had stage cT3 or cT4, and 121 patients (85.8%) had positive lymph nodes. The location of the tumors was in the lower rectum in 88 patients (62.4%). After neoadjuvant chemoradiotherapy, 113 patients (80.1%) underwent sphincter-preserving resection. Downstaging was observed in 121 patients (85.8%), including 80 patients (56.7%) with T downstaging and 101 patients (83.5%) with N downstaging. Thirty-two patients (22.7%) obtained pathological complete response (pCR). The median follow-up was 38.5 months (range, 9.3–73.6 months). Only 36 patients (25.5%) experienced treatment failure, including distant metastasis in 29 patients (20.6%) and pelvic recurrent in 7 patients (5.0%). The estimated 5-year overall survival (OS), disease-free survival (DFS), and local control (LC) rates of patients were 75.1%, 70.9%, and 95.5%, respectively. pCR was an independent prognostic factor for DFS (HR 0.13, 95% CI: 0.02–0.93, P = 0.043), but it did not improve OS or LC. Grade 3 or greater acute leukopenia and diarrhea rates were 5.7% and 7.8%, respectively, and 15 patients (10.6%) developed postoperative complications. Conclusion: This study indicates that neoadjuvant, image-guided Tomotherapy with 55 Gy boosted to the primary tumor was well tolerated and resulted in high rates of sphincter-preserving surgery, pCR, LC, and DFS for locally advanced rectal cancer. Keywords: rectal cancer, neoadjuvant chemoradiotherapy, dose escalation, pathological complete response, Tomotherapy
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